Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02430831
Recruitment Status : Unknown
Verified April 2015 by Flavia Indrio, University of Bari.
Recruitment status was:  Not yet recruiting
First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborators:
Antonio Di Mauro
Ruggiero Francavilla
Lorenzo Trovè
Information provided by (Responsible Party):
Flavia Indrio, University of Bari

Brief Summary:

Study type:

Randomized controlled trial with two parallel arms Objectives

Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 measured as

  1. the number of "responders" or the "treatment success" (ie infants for which defined as the percentage of children achieving a reduction in the daily average crying time >50% in 3 weeks. (day 1 to day 21 of the study)
  2. maternal depression and family functioning scoring

Condition or disease Intervention/treatment Phase
Infantile Colic Dietary Supplement: Nidina Dietary Supplement: Placebo Phase 4

Detailed Description:

Inclusion criteria :

  • less then 12 weeks of age
  • term infant (≥ 38 weeks gestational age)
  • birth weight > 2,500g
  • infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
  • parental motivation to postpone changes in the infant feeding mode, unless necessary

Exclusion criteria:

  • birth weight less than 2500 g
  • failure to thrive
  • chronic illness or major medical problem
  • gastrointestinal disease
  • cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
  • use of any antibiotic or probiotic in the week (7 days) prior to enrollment
  • use of proton pump inhibitors in the week (7 days) prior to enrollment
  • if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment
  • infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
  • change of feeding mode planned by parents during the study period

Randomization and blinding: to be written by the CRO, according to its own procedures.

Extreme caution should be given to blinding. Methods should give full certainty that blinding was perfect at the subject (parent) level, but also at the pediatrician and with all involved personnel.

Randomization should be done according to 3 feeding modes :

  • "breast feeding: only breast, except for 2 bottle feedings a week,
  • "formula fed": only formula except two breast feeding a week,
  • "mixed feeding": all the remaining

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Testing the Effect of Milk Formula Supplemented With L. Reuteri on Crying Time in Colicky Infants Less Than 3 Months Old
Study Start Date : May 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Arm Intervention/treatment
Active Comparator: Reuteri group
Milk formula added with probiotic L reuterii DSM 17938
Dietary Supplement: Nidina
Placebo Comparator: Placebo
Milk formula without probiotic L reuterii DSM 17938
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Daily Crying duration [ Time Frame: three days ]
    The average crying time in minutes per day measured on day 19, 20, and 21 between active and placebo groups.


Secondary Outcome Measures :
  1. Rate of success (decrease in mean daily crying time) [ Time Frame: 3 days ]
    Percentage of infants in the active group compared to the placebo group in whom the mean of daily crying time of the days 19, 20 and 21 decreased by 50% compared to the three days prior to recruitment.

  2. Family functional score (family functioning scale) [ Time Frame: one day ]
    The score achieved in the family functioning scale at day 21.

  3. Mother depression (mother depression Scale) [ Time Frame: One day ]
    The score achieved in the mother depression Scale at day 21.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria :
  • less then 12 weeks of age
  • term infant (≥ 38 weeks gestational age)
  • birth weight > 2,500g
  • infantile colic diagnosed according to modified Wessel's criteria, i.e. crying more than an average of 180 min/day during the 3 days prior to enrollment.
  • parental motivation to postpone changes in the infant feeding mode, unles

Exclusion Criteria:

  • - birth weight less than 2500 g
  • failure to thrive
  • chronic illness or major medical problem
  • gastrointestinal disease
  • cow's milk allergy ( confirmed prior to exclusion; difficult to diagnose so early ??)
  • use of any antibiotic or probiotic in the week (7 days) prior to enrollment
  • use of proton pump inhibitors in the week (7 days) prior to enrollment
  • if breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrollment
  • infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
  • change of feeding mode planned by parents during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430831


Contacts
Layout table for location contacts
Contact: Flavia Indrio, MD f.indrio@alice.it

Locations
Layout table for location information
Italy
University of Bari
Bari, BA, Italy, 70124
Sponsors and Collaborators
University of Bari
Antonio Di Mauro
Ruggiero Francavilla
Lorenzo Trovè
Investigators
Layout table for investigator information
Principal Investigator: Flavia Indrio, MD University of Bari

Layout table for additonal information
Responsible Party: Flavia Indrio, MD, University of Bari
ClinicalTrials.gov Identifier: NCT02430831     History of Changes
Other Study ID Numbers: VF/FC
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Colic
Infant, Newborn, Diseases